UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000011757
Receipt No. R000013673
Scientific Title Utility of acupuncture and moxibustion for repositioning breech presentation. -Randomized Controlled Trial-
Date of disclosure of the study information 2013/09/17
Last modified on 2013/09/13

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Utility of acupuncture and moxibustion for repositioning breech presentation.
-Randomized Controlled Trial-
Acronym Effect of acupuncture and moxibustion for repositioning breech presentation.
Scientific Title Utility of acupuncture and moxibustion for repositioning breech presentation.
-Randomized Controlled Trial-
Scientific Title:Acronym Effect of acupuncture and moxibustion for repositioning breech presentation.
Region
Japan

Condition
Condition Breech presentation
Classification by specialty
Obsterics and gynecology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Our study's aim is examination about that acupuncture and moxibustion effect on breech presentation for repositioning, general malaise, and physical complaiant
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1) First outcomes : Repositioning
2) second outcomes: Guestionnaire of general malaise.
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control No treatment
Stratification NO
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking YES
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 acupuncture and moxibustion
Interventions/Control_2 observe
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
45 years-old >=
Gender Female
Key inclusion criteria women's first childbirth and 30 weeks of pregnancy and breech presentation.
Key exclusion criteria pregnant women have being treatment of acupuncture and moxibustion from gestation.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Katai Shuichi
Organization Tsukuba University of Technology
Division name professor of science of health
Zip code
Address Ibaraki Tsukuba city kasuga 4-12-7
TEL 029-858-9533
Email katai@k.tsukuba-tech.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tsujiuchi Keiko
Organization SERIE woman's health care
Division name director
Zip code
Address Kanagawa Yokohama city naka-ku hanasakichou 1-5-704
TEL 045-262-5550
Homepage URL
Email czw06225@nifty.com

Sponsor
Institute Tsukuba University Of Thechnology
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization Foundation for training and licensure examination in ammma-massage-acpressure,acpuncture and moxibution
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions よしかた産婦人科(神奈川県)

Other administrative information
Date of disclosure of the study information
2013 Year 09 Month 17 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Preinitiation
Date of protocol fixation
2013 Year 04 Month 30 Day
Date of IRB
Anticipated trial start date
2013 Year 09 Month 17 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 09 Month 13 Day
Last modified on
2013 Year 09 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013673


Contact us.